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May 22, 2026
A comparative study found Canadian patients waited more than 90 weeks longer than Americans and 65 weeks longer than Europeans for new drugs approved between 2019 and 2025. The report said late submissions to Health Canada, along with price controls and other market factors, were the main drivers.
May 13, 2026
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
May 11, 2026
A pooled analysis of five randomized trials found intranasal esketamine improved MADRS scores in adults with TRD in both sexes. Females showed greater improvement and higher odds of treatment-response toward trial end.
May 01, 2026
Aurobindo Pharma's subsidiaries secured Health Canada approval for bevacizumab biosimilar Bevqolva, an EU distribution deal with STADA for two EMA-approved biosimilars, and US FDA approval for ADQUEY ointment for atopic dermatitis.
Apr 29, 2026
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Mar 02, 2026
Canada's Drug Agency issued a draft recommendation against public drug plan coverage for lecanemab, an Alzheimer's treatment conditionally approved by Health Canada in October 2025, citing cost concerns despite the drug's ability to slow cognitive decline.
Feb 25, 2026
Health Canada released proposed Clinical Trials Regulations in December 2025 that would establish a new regulatory framework for drug trials, replacing existing rules with a streamlined, risk-based approach aimed at improving access to innovative therapies.
Feb 25, 2026
Cytokinetics launches MYQORZO for obstructive hypertrophic cardiomyopathy following FDA approval, while C4 Therapeutics doses first patient in Phase 2 trial of cemsidomide for relapsed/refractory multiple myeloma.
Feb 17, 2026
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
Feb 17, 2026
Merck secures regulatory approvals for Keytruda in ovarian cancer and subcutaneous formulation in Canada, while launching AI-driven drug discovery partnership with Mayo Clinic targeting high-need therapeutic areas.
Feb 13, 2026
Natco Pharma has received approval from India's CDSCO to manufacture and market generic semaglutide injection, with a March 2026 launch planned. The approval comes amid patent litigation and intense competition in India's rapidly expanding diabetes and obesity drug market.
Dec 11, 2025
Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.
